Associate Director, QC Analytics Lifecycle Lead

AstraZeneca plc; Rockville (MD); On-site; USD 135,000 - 203,000; Full time

Job summary

AstraZeneca plc in Rockville, MD, seeks an Associate Director, QC Analytical Lifecycle Management, to lead strategic and technical analytics for GMP manufacturing and product testing. You will drive the lifecycle of analytical methods from transfer to retirement, collaborating with QC, Development, Manufacturing, QA, Regulatory, and external labs.

The role emphasizes regulatory alignment, data integrity, and risk-based decision making in a fast-paced environment, with a focus on patient safety

Qualifications

• Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences or related field.
• 8+ years in biopharmaceutical/biotech/pharma development, manufacturing, or QC; 6+ years with MS/PhD.
• 2+ years of managerial or supervisory experience.
• Extensive GMP analytical testing and lifecycle activities like transfer, qualification, validation, verification and monitoring.

Responsibilities

• Provide strategic, scientific leadership for GMP analytical operations across manufacturing, product testing, lifecycle management, and readiness.
• Lead method transfer, qualification, validation, verification, and troubleshooting with lifecycle oversight.
• Establish technical strategies for laboratory readiness including instrumentation, materials, references, and data systems.
• Oversee investigations, deviations, CAPAs, and risk assessments with analytical focus.
• Collaborate across QC, Analytical Development, Manufacturing, QA, Regulatory CMC, and external partners.
• Ensure methods and control strategies are scientifically sound and compliant with GMP and data integrity principles.

Skills

GMP experience

Analytical method lifecycle

Cross-functional leadership

Regulatory compliance

Data integrity

Project management

Education

Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences

MS or PhD in a related field

Job description

AstraZeneca plc in Rockville, MD, seeks an Associate Director, QC Analytical Lifecycle Management, to lead strategic and technical analytics for GMP manufacturing and product testing. You will drive the lifecycle of analytical methods from transfer to retirement, collaborating with QC, Development, Manufacturing, QA, Regulatory, and external labs.

The role emphasizes regulatory alignment, data integrity, and risk-based decision making in a fast-paced environment, with a focus on patient safety